Glatiramer Acetate (Copaxone®) Study to Follow Participants From the First Original Study for Safety and Effectiveness

NCT ID: NCT00203021

Last Updated: 2020-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1994-03-26
• Study Completion Date: 2018-02-28

Brief Summary

This open-label extension study will evaluate the long-term safety of glatiramer acetate and its effect on the neurologic course of participants with relapsing-remitting multiple sclerosis (RRMS). Participants have scheduled visits every 3 months to assess glatiramer acetate safety and their Multiple Sclerosis (MS) status.

Conditions

Relapsing-Remitting Multiple Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Glatiramer Acetate: Delayed Start

Participants who were originally randomized to the placebo group in the 01-9001 and/or the 01-9001E studies received glatiramer acetate 20 milligrams (mg) subcutaneous (SC) injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg three times weekly (TIW). The treatment continued for up to 288 months.

Group Type: EXPERIMENTAL

Glatiramer acetate

Intervention Type: DRUG

Glatiramer acetate will be administered as per the dose and schedule specified in the respective arms.

Glatiramer Acetate: Early Start

Participants who were originally randomized to the glatiramer acetate 20 mg group in the 01-9001 and/or the 01-9001E studies continued to receive glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.

Group Type: EXPERIMENTAL

Glatiramer acetate

Intervention Type: DRUG

Glatiramer acetate will be administered as per the dose and schedule specified in the respective arms.

Interventions

Glatiramer acetate

Glatiramer acetate will be administered as per the dose and schedule specified in the respective arms.

Intervention Type: DRUG

Other Intervention Names

Copaxone®

Eligibility Criteria

Inclusion Criteria

• Participants must have participated (been randomized) in the Copaxone double-blind placebo-controlled study 01-9001 and/or the double-placebo-controlled extension study 01-9001E.
• Participants could be male or female. Women of childbearing potential must have practiced an acceptable method of birth control.
• Participants must have completed the scheduled termination visit for Amendment 12 (Month 264).
• Participants must have signed an approved informed consent form (ICF) prior to continuing in the study extension or at the first visit in the extension (Month 264 which corresponds to the termination visit of Amendment 12).
• Participants must have been psychologically and physically stable to participate in the trial as judged by the investigator.
• All participants enrolled in this extension study were required to have the following study-specific baseline characteristics prior to entry to Study 01-9001: a diagnosis of RRMS as defined by Poser et al 1983, at least 2 clearly identified relapses and remissions in the 2-year period prior to study entry, ambulatory with a Kurtzke EDSS score of 0 to 5.0 inclusive, and a stable neurologic state for at least 30 days prior to study entry.

Exclusion Criteria

• Pregnancy or lactation.
• Medical or psychiatric conditions that affect the participant's ability to give informed consent or complete the study.
• Inability to self-administer subcutaneous medication or lack of another responsible individual to administer the study preparation daily.
• Use of approved MS therapies including interferons, experimental MS therapies, or previous immunosuppressive therapy with cytotoxic chemotherapy (azathioprine, cyclophosphamide, or cyclosporine).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cory Ford, MD

Role: STUDY_DIRECTOR

University of New Mexico

Locations

Teva Investigational Site 009

Los Angeles, California, United States

Teva Investigational Site 004

Los Angeles, California, United States

Teva Investigational Site 008

New Haven, Connecticut, United States

Teva Investigational Site 005

Baltimore, Maryland, United States

Teva Investigational Site 003

Detroit, Michigan, United States

Teva Investigational Site 002

Albuquerque, New Mexico, United States

Teva Investigational Site 007

Rochester, New York, United States

Teva Investigational Site 001

Philadelphia, Pennsylvania, United States

Teva Investigational Site 010

Houston, Texas, United States

Teva Investigational Site 006

Salt Lake City, Utah, United States

Teva Investigational Site 011

Madison, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

01-9004

Identifier Type: OTHER

Identifier Source: secondary_id

GA-9004

Identifier Type: -

Identifier Source: org_study_id